Factors influencing patient adherence and persistence to hormonal therapy drugs in treatment of breast cancer

textThe purpose of this study was to investigate the relationship between patient out-of-pocket costs and adherence and persistence to hormonal therapy (HT) used in treatment of breast cancer. A retrospective analysis of medical and prescription drug claims for patients with breast cancer (N=6,504) was conducted to estimate the medication possession ratio; adherence; days of persistence; persistence; HT out-of-pocket costs, and total out-of-pocket costs, over 12 months after index HT and over the study period. The multivariate linear regression, logistic regression, and the Cox proportional hazard regression were employed to evaluate the association. The mean (SD) MPR over the 12 months and the study period was 85.6 (23.5) and 89.3 (16.1) percent, respectively. The MPR was positively related to HT out-of-pocket costs and not related to total out-of-pocket costs. Of the study sample, 75.1 percent of the patients were adherent (MPR≥80 percent) to HT over the 12 months period and 82.0 percent were adherent over the study period. The adherence to HT was positively related to HT out-of-pocket costs but not related to total out-of-pocket costs. The mean (SD) days of persistence over the 12 months and the study period were 313.3 (97.8) and 826.8 (583.7) days, respectively. HT out-of-pocket costs and total out-of-pocket costs were inversely related to risk of discontinuation over the 12 months period. The HT out-of-pocket costs and risk of discontinuation were inversely related over the study period. No relationship was observed between total-out-of-pocket costs and risk of discontinuation over the study period. A total of 68.2 percent of the patients were persistent to their therapy for the 12 months and 30.9 percent were persistent (gap of 60 days or less in continuous therapy) for the study period. A positive relationship was observed between HT out-of-pocket and total out-of-pocket costs and persistence during the 12 months period. The study period analyses showed positive relationship between HT out-of-pocket costs and persistence and no relationship between total out-of-pocket costs and persistence. The results show that patient HT adherence and persistence is poor; however, patient HT and total out-of-pocket costs do not have an adverse effect on adherence and persistence.Pharmaceutical Science

Impact of Medicare part D on adherence and persistence to statin medications for Texas dual-eligible beneficiaries

textStatins are commonly used for treating the elevation of lipids in the blood stream, also known as hyperlipidemia. Statins are considered to be an economical and effective way to achieve desirable long-term health outcomes for hyperlipdemic patients, however, ensuring adequate adherence to statin medications is often difficult as hyperlipidemia is an asymptomatic condition and patients sometimes fail to recognize the importance of being adherent to their statin medications. The purpose of this study was to evaluate impact of enrollment under Medicaid and Medicare Part D and patient out-of-pocket costs on patient statin adherence, persistence, and mean number of gap days per claim. A retrospective claims database was used in this study to conduct repeated measures analyses on statin prescription claims from independent community pharmacies in Texas. The pre-period in this study extended from January 1, 2005 to September 30, 2005 (Medicaid period) and the post-period extended from January 1, 2006 to September 30, 2006 (Medicare period). The study population consisted of dual-eligible beneficiaries in Texas who had at least two stain claims in the pre and post-periods each. The final study population comprised of 1734 Texas dual-eligible beneficiaries with 6064 statin claims during the pre-period and 7956 claims during the post-period. Patients had an average of 3.49 statin claims during the pre-period and 4.58 statin claims during the post-period. Patients were dispensed an average of 57.34 days of drug supply per claim during the pre-period and 42.02 days of drug supply per claim during the post-period. The results from this study showed that out-of-pocket costs for patients increased from $0.39 per claim under Medicaid to$13.36 per claim under Medicare Part D. Patient adherence to statins was assessed by calculating medication possession ratio (MPR). The results showed that mean patient MPR increased from 75.71 percent under Medicaid to 79.37 percent under Medicare. Results from generalized estimating equations showed that odds of being adherent (i.e., MPR ≥ 80 percent) to statins increased by 36 percent when patients were covered under Medicare Part D. Linear mixed model analysis showed that MPR increased by 3.66 percent when patients were covered under Medicare Part D compared to Medicaid. Also, patient MPR was found to increase by 0.13 percent when patient out-of-pocket payment increased by $1.00. Patient persistence was calculated by measuring gaps in therapy and patients with a gap of 60 or more days were considered to have discontinued therapy. Patients were found to be persistent to their drug therapy for an average of 151.76 days under Medicaid and 159.75 days under Medicare. Linear mixed model analysis showed that patient persistence increased by 7.99 days when patients were enrolled under Medicare Part D compared to Medicaid. Days of persistence was also found to increase by 0.41 days when patient out-of-pocket costs increased by$1.00. Mean number of gap days per claim during the Medicaid period was 11.91 days and decreased to 8.38 days during the Medicare period. Linear mixed model analysis showed that mean number of gap days per claim decreased by 3.52 days when patients were enrolled under Medicare Part D compared to Medicaid. Mean number of gap days in therapy were found to decrease by 0.10 days when patient out-of-pocket costs increased by $1.00. The results of this study showed that implementation of Medicare Part D resulted in an increase in MPR and persistence and a decrease in mean number of gap days per claim for Texas dual-eligible beneficiaries. The results also suggest that increased out-of-pocket costs under Medicare Part D may not have had a negative impact on statin drug utilization by dual-eligible beneficiaries in Texas.Pharmac

Toxicity Burden of Bleomycin Treatment in Hodgkin Lymphoma: A Systematic Literature Review

Abstract Introduction: Bleomycin has been a component of chemotherapeutic regimens for decades, typically among young individuals who may survive for long periods. Yet, toxicity from bleomycin may result in short-term and long-term health problems. The study objectives were to characterize the occurrence and severity of bleomycin toxicities and identify risk factors for bleomycin toxicity among patients with Hodgkin lymphoma. Methods: A systematic literature review of the burden of bleomycin treatment in cancer patients was conducted using the PRISMA checklist. PubMed, EMBASE, and Cochrane Database were searched for English language articles between 1980 and March 2016 providing data on bleomycin toxicity in studies with &gt;10 patients. Results: Overall, 18 original research articles of good to moderate quality were included in the systematic review for patients with Hodgkin lymphoma. Pulmonary toxicity ranged from dyspnea, pulmonary fibrosis, and pneumonitis, to acute respiratory distress syndrome and respiratory tract disorders or infections. For Hodgkin lymphoma, the proportion of patients experiencing pulmonary toxicity was &gt;5% in 12 of 17 studies, with 8 studies reporting toxicity in 13% - 28% of patients. Other studies (n=5) reported that 0% - 4.7% of patients experienced pulmonary toxicity. About 4% -5% of Hodgkin lymphoma patients had fatal pulmonary toxicity. Skin toxicity ranged from skin rash to dermatitis and erythema, with 1% - 5% of Hodgkin lymphoma patients experiencing skin toxicity after bleomycin exposure. In the 4 studies that investigated risk factors for bleomycin-induced pulmonary toxicity among patients with Hodgkin lymphoma, low albumin level (&lt;40 g/dL), treatment with anthracycline containing chemotherapy regimens and use of colony granulocyte stimulating factor concomitant with bleomycin were reported to be significant risk factors. No significant difference was found between patients with and without pulmonary toxicity in terms of exposure to radiation therapy, cumulative bleomycin dose, smoking history, or underlying lung involvement. Conclusions: Long-term pulmonary toxicity was not consistently evaluated in the studies and may understate the true burden on patients. Many patients treated with bleomycin may experience toxicity and sometimes fatal toxicity. Since Hodgkin lymphoma is a highly curable malignant disease and to further improve patient outcomes, attention needs to be focused on reducing treatment-related toxicities, particularly long-term morbidity and death associated with pulmonary events. Disclosures Fox: Seattle Genetics: Research Funding. Josephson:Seattle Genetics: Employment. Richhariya:Seattle Genetics, Inc.: Employment. </jats:sec

Abstract P374: Incidence and Costs of Cardiovascular Events among High Risk Patients with Hyperlipidemia

Background: Advances in cardiovascular (CV) disease management have reduced acute CV event risk; however, the burden of these events remains substantial. We identified a cohort of high risk coronary heart disease risk equivalent patients to examine the incidence of subsequent inpatient CV events and cost of first, subsequent and fatal inpatient CV events. Methods: The Truven Health MarketScan® Commercial Database was used to identify adults with hyperlipidemia or lipid-lowering therapy in the 18 months prior to one of the following new inpatient CV events: myocardial infarction (MI), ischemic stroke, unstable angina (UA), revascularization without MI, UA, or stroke (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI]), or heart failure between 2006 and 2012. Patients were required to have a pre-index diagnosis of peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease or diabetes (CHD RE). Direct medical costs were reported for each three-month quarter following a CV event, for up to 36 months after the first CV event. Fatal CV events were identified for a subset of patients with Social Security Administration Master Death File (SSAMDF) data to determine presence of death within 90 days of a CV event. Results: A total of 38,609 CHD RE patients met the study criteria (mean age 57 years, 69% male). CABG, MI and PCI were the most frequent and most expensive first CV events, accounting for &gt;75% of all first CV events. Mean quarter 1 (Q1) non-fatal and fatal direct costs were highest for CABG ($77,701 and$125,690), followed by MI ($47,869 and$56,577) and PCI ($38,744 and$64,387). First event stroke, TIA and UA mean Q1 direct costs ranged from a low of $17,454 (non-fatal TIA) to a high of$72,449 (fatal UA). Overall, 15% of those with a first CV event went on to have a second event during the 36 month study period, with an average time to event of 217 days. Of patients with SSAMDF availability, 1.8% of acute CV events were fatal (range 1-4% by event type) and average Q1 costs for fatal events were 1.5 times higher than average costs for non-fatal events (range 1.2-5.5 times). Overall, 2.8% of patients went on to have a third acute CV event, occurring on average 230 days following the second event. Mean quarterly costs in Q2 drop substantially to between 8.2% (CABG) and 33.6% (TIA) of Q1 event costs. Average quarterly costs stabilized at approximately 1.4 times higher than average pre-event costs for Q3 through Q12; costs never returned to pre-event levels. Conclusions: MI was the most common first inpatient CV event in high risk CHD RE patients. Recurrent CV events are common and occur, on average, within 8 months. CV events were costly, regardless of sequence, averaging $47,433 in the first 90 days following an event. During the follow-up period, costs never returned to their pre-event levels. Though uncommon, fatal CV events have substantially higher costs than non-fatal events. </jats:p

Systematic Literature Review of the Global Incidence and Prevalence of Myelodysplastic Syndrome and Acute Myeloid Leukemia

Abstract Introduction: Acute myeloid leukemia (AML) consists of a group of relatively well-defined hematopoietic neoplasms, while myelodysplastic syndrome (MDS) comprises a heterogeneous group of hematopoietic stem cell disorders. These disorders may occur de novo or may arise secondary to prior malignancies for which patients received cytotoxic chemotherapy and/or radiation therapy. While AML and MDS are reported in a number of national cancer registries, competing classifications prior to 2001 often preclude comparison of results globally. We conducted a systematic literature review in order to identify global rates of the incidence and prevalence of AML and MDS. Methods: We searched Embase and MEDLINE for published studies and recent conference abstracts on the incidence and/or prevalence of AML and MDS for data collected from 2001-2016. This time period parallels the introduction of the World Health Organization (WHO) classification of hematopoietic neoplasms. Two reviewers independently screened all abstracts and selected articles, and subsequently abstracted multiple data elements including: AML or MDS, geographic region, standardized incidence and/or prevalence rates, years of data collection, disease classification criteria (e.g. WHO, French American British (FAB), ICD-O-3, ICD-9/10), if condition was diagnosed de novo or treatment associated, age category, and gender. Incidence rates and prevalence by sub-disease classification were also abstracted when available. Results: Literature Review: Our search strategy yielded 874 abstracts initially reviewed for applicability. Of these, 84 were selected for article screening; 44 articles were excluded after screening and 40 articles proceeded to data abstraction and were included in analyses. 25 studies reported on MDS incidence and 2 on MDS prevalence; 17 studies reported on AML incidence and 4 on AML prevalence (some studies report both AML and MDS and incidence and prevalence). While the majority of studies are based on existing regional disease registries, a number describe analyses based on administrative claims data, or patient charts. Nine (9) studies reported on therapy associated incidence. Classification of AML or MDS was based on FAB (9 studies), WHO (10 studies), ICD-O-3 (11 studies) or ICD-9/10 (7 studies) criteria. Three studies were classified on the basis of chart review and/or clinical diagnosis by a physician. Regional distribution was: North America (10 studies), Europe (17 studies), Australia (4 studies), and the Rest of World (including 3 studies in Asia, 2 studies in Africa, 2 in South America and 2 in the Middle East). Analysis: Incidence rates are reported in Figure 1 by region for those studies reporting overall rates across clinical factors, age and gender (27 articles). Incidence of AML as a result of treatment for another cancer ranged from 0.06-2.6 per 100,000 and for MDS from 0.06-0.26 per 100,000. In general, incidence rates increased with increasing age in studies that reported results by age group. Prevalence of AML ranged from 0.6-11.0 per 100,000 and for MDS ranged from 0.22-13.2 per 100,000 for all age categories, genders and ethnicities. Discussion:This is the first study to report on the global incidence of AML and MDS and whether or not the disease occurs as a result of treatment for another oncologic condition or occurs de novo. Variation in study designs and heterogeneous population characteristics make interpretation of results challenging. Figure 1 Overall Incidence Rates for AML and MDS by Geographic Region Figure 1. Overall Incidence Rates for AML and MDS by Geographic Region Disclosures Lubeck: Outcomes Insights: Employment. Danese:Outcomes Insights: Employment. Jennifer:Outcomes Insights: Employment. Miller:Outcomes Insights: Consultancy. Richhariya:Seattle Genetics, Inc.: Employment. Garfin:Seattle Genetics, Inc.: Employment. </jats:sec